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Background to studies

Certain CMR 1A and 1B substances in articles

"The potential impact on industrial competitiveness of restrictions on certain CMR 1A and 1B substances in articles - Scoping study for the application of art. 68(2) of REACH to CMR substances requiring priority action”

DG Enterprise signed a contract with ICF International in December 2012, with the following objectives:

  • to gather information on the presence of specific CMR substances 1A and 1B in articles and
  • to investigate the current market distribution, including the availability of alternatives and the potential socio-economic impact for industry of potential restriction(s).

The main objective of the project is to elaborate criteria for the implementation of art. 68(2) of REACH. This article foresees a special restriction procedure for CMRs 1A and 1B present in articles that might be used by consumers.

ICF distributed a questionnaire to REACH competent authorities and to stakeholders at the end of February 2013, to start collecting information on the presence of 44 selected substances in consumers’ articles. The list of substances included in the study is on page 6 of the questionnaire. This questionnaire, as a preliminary investigation, will try to gather possible information about the presence of these substances in articles, in order to gather a better understanding on the use of these substances, on their market distribution and on the availability of alternatives,  with information on exposure if it really occurs. It should not be seen as a statement of intention to take regulatory action in respect of these substances.

Questionnaire for all stakeholders pdf - 2 MB [2 MB] (only available in English)

The information collected in this stage focused on the presence of specific CMR substances in articles, their function, EU and non-EU market for substances and articles, market players, possible information on exposure to  consumers and possible alternatives.

A certain number of substances was selected from the initial list to undergo a more detailed socio-economic impact analysis. Ad hoc interviews were organised by the consultant with relevant stakeholders. The project finished in November 2013.

In the next phase, the Commission will use the findings of the project to define, in agreement with Member States Competent Authorities, the criteria for the implementation of art. 68(2).

For more information on the project, you can contact Valentina Bertato (valentina.bertato@ec.europa.eu).

1,4 DICHLOROBENZENE

Questionnaires to gather information on the manufacturing, import and use of 1,4 dichlorobenzene in air fresheners and toilet blocks - deadline was 13 November 2009

DG Enterprise and Industry has commissioned the consultant Risk&Policy Analysts, RPA, to conduct a study on the economic and social analysis on the use of 1,4 dichlorobenzene in air fresheners and toilet blocks.

Under Article 137 of REACH, by 1 June 2010, the Commission shall, if necessary, prepare a draft amendment to Annex XVII in accordance with any risk evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11 of Regulation (EEC) No 793/93 as far as it includes proposals for restrictions in accordance with Title VIII of REACH but for which a decision under Directive 76/769/EEC has not yet been taken.

A risk assessment was carried out in accordance with Council Regulation (EEC) No 793/93 by the Rapporteur France; the final report has been published in 2004 on the European Chemicals Bureau website. In February 2008 the Commission Communication on the results of the risk evaluation and the risk reduction strategies for 1,4 dichlorobenzene was published in the Official Journal of the European Union. This Commission Communication recommends that in order to limit the risk for consumers, marketing and use restrictions in Directive 76/769/EEC should be considered for the use of 1,4 dichlorobenzene in air fresheners, moth repellents and toilet blocks.

The objective of this study is to collect information to perform an economic and social analysis on the use of 1,4 dichlorobenzene in air fresheners and toilet blocks.

The study was to be finalized by the end of February 2010.

In order to facilitate the exchange of information and to involve the maximum number of Participants, the relevant questionnaires are made available on this website. In the meantime, RPA will contact and will send these questionnaires to all the Competent Authorities and to the stakeholders, who are already known.

All contributions are welcome. The completed questionnaire must be sent by email, fax or post, only to the Consultant RPA , by 13 November 2009, to the address given below:

Panos Zarogiannis

Risk & Policy Analysts

1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK

Tel: +44 1508 528465

Fax: +44 1508 520758

e-mail: panos.zarogiannis@rpaltd.co.uk

- Questionnaire for Member States msw8 - 119 KB [119 KB]

- Questionnaire for Manufacurers-Importers of 1,4 dichlorobenzene msw8 - 283 KB [283 KB]

- Questionnaire for Manufacturers, Suppliers and Importers of products containing 1,4 dichlorobenzene msw8 - 368 KB [368 KB]  

PFOA

Questionnaire for Manufacturers/Importers and Downstream Users on emission and exposure of PFOA msw8 - 238 KB [238 KB]

deadline was 31/07/2009

Questionnaires to gather information on the manufacturing, import and use of PFOA and related compounds in Europe

DG Enterprise and Industry has commissioned RPS Advies to conduct a study on certain perfluoroalkyl compounds. The EU Directive 2006/122/EC, amending for the 30th time the Council Directive 76/769/EEC) introduces restrictions on the marketing and use of perfluorooctane sulfonates (PFOS). Point 8 of the Annex of that Directive states:

"The Commission shall keep under review the ongoing risk assessment activities and the availability of safer alternative substances or technologies related to the uses of perfluorooctanoic acid (PFOA) and related substances and propose all necessary measures to reduce identified risks, including restrictions on marketing and use, in particular when safer alternative substances or technologies, that are technically and economically feasible, are available."

The present study will build on the results of the hazard assessment carried out by the OECD in 2008 and will assess the risks of these substances during industrial uses and in consumer products.

The objective of this study is to collect information to assess the risks to workers, the environment and consumers and the potential socio-economic impact of possible restrictions on the marketing and use of PFOA (and related compounds) with a view to advise on whether derogations could be justified for certain uses of PFOA and related compounds.

Directive 2006/122/EC relating the restrictions on marketing and use on PerFluoroOctane Sulfonic acid (PFOS) and related compounds requires the European Commission to:

· keep under review the ongoing risk assessment activities on PerFluoroOctanoid Acid (PFOA) and to propose necessary measures to reduce the risks if needed,

· investigate those industrial uses of PFOS and related compounds excluded from the restrictions.

This study will also include an evaluation of the alternatives to PFOS for those uses, exempted by the restrictions such as photoresists, photographic coatings, hydraulic fluids for aviation and chromium electroplating process. This analysis will help the Commission to monitor the development of possible alternatives or technologies.

The study was to be finalised by the end of October 2009

In order to facilitate the exchange of information and to involve the maximum number of participants, the following questionnaires will be sent by RPS Advies to the Competent Authorities, manufacturers, importers, users of these substances and other known stakeholders.

All contributions are welcome. The completed questionnaire must be sent by e-mail (preferred), post or fax to RPS Advies by 31 March 2009 at the address given below:

RPS Advies BV

Attn. Martijn van Velthoven (PFOA study) P.O. Box 5094, 2600 GB Delft, The Netherlands Tel: +31 629 621 448 / +31 15 750 1610 Fax: +31 15 750 1610 e-mail: PFOreply@rpsgroup.com

· Questionnaire for Member states msw8 - 205 KB [205 KB]

· Questionnaire for Manufacturers msw8 - 161 KB [161 KB]

· Questionnaire for Downstream users msw8 - 197 KB [197 KB]

· Questionnaire for Stakeholders msw8 - 174 KB [174 KB]

BORATES

Questionnaires to gather information on certain uses of borates in Europe

DG Enterprise and Industry has commissioned the consultant Risk&Policy Analysts, RPA, to conduct a study on certain borate compounds which have been recently proposed to be classified as reprotoxic category 2 (respectively under the 30 and 31 Adaptations to Technical Progress of Directive 67/548/EEC). As a consequence, the Commission is required within six months of their classification to propose a ban on their placing on the market and use by consumers as substances or in preparations. Exceptions may be made in cases where there are no unacceptable risks or where the socio-economic benefits from using the substance(s) outweigh the risks.

The objective of this study is to collect information to assess the risks to consumers and the potential socio-economic impact of possible restrictions on the marketing and use of borates in preparations sold to the general public with a view to advise on whether such exceptions could be justified for certain uses of the borates, if appropriate.

The study was to be finalised by the end of September 2008.

In order to facilitate the exchange of information and to involve the maximum number of Participants, the relevant questionnaires are made available on this website. In the meantime, RPA will contact and will send these questionnaires to all the Competent Authorities and to the stakeholders, who are already known.

All contributions are welcome. The completed questionnaire must be sent by email, fax or post, only to the Consultant RPA, by 16 May 2008, to the address given below:

Tobe Nwaogu

Risk & Policy Analysts

1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK

Tel: +44 1508 528465

Fax: +44 1508 520758

e-mail: tobe@rpaltd.co.uk

 

 

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